PUR BIOLOGICS, LLC

FDA Device Registration & Listing · Irvine, CA, US · Registration 3010770940

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3010770940
FEI Number
3010770940
Entity Name
PUR BIOLOGICS, LLC
City/State/Country
Irvine, CA, US
Establishment Address
16520 Bake Pkwy Ste 105, Irvine, CA 92618, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
PUR Biologics, LLC (Owner Number: 10046283)
Owner / Operator Contact Address
16520 Bake Pkwy, Suite 105, Irvine, CA 92618, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K053213
PMA Number
N/A

All Registered Proprietary Names

PUR pillars PUR crystals PUR core PUR fuze PUR Bioglass Bridge PUR basic

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2022-10-24

Official Correspondent

Ryan Fernan

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PUR Biologics, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K180121 Cellumed Co., Ltd. Rafugen DBM 2018-04-11
K062691 Takiron Co., Ltd. COMPORUS 2008-04-15
K023703 Berkeley Advanced Biomaterials, Inc. BI-OSTETIC 2003-01-30
K173933 Xenco Medical, LLC Sorrento Bioglass Bone Graft Substitute 2018-09-13

Similar Registrations

Registration Number Establishment Name Location
3007738819 OSferionBiomaterials Corp. Mishima Factory Sunto-gun Shizuoka, JP
3019403037 HERAEUS MEDICAL LLC - BIORESOBABLES Yardley, PA, US
3010376334 GEV Co., Ltd. Eumseong-gun Chungbuk, KR
3043620406 REVOGEN BIOLOGICS San Antonio, TX, US
3016050940 Olive Branch Distribution Center Olive Branch, MS, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010770940. Last updated year: 2026. Please use registration number 3010770940 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.